The signaling layer
beneath the cell.

Exosomes are 30–150 nm extracellular vesicles secreted by mesenchymal stem cells. They carry a payload of proteins, lipids, and nucleic acids (mRNA, microRNA) and serve as the cell's native delivery system for paracrine signaling — the way one cell instructs another without direct contact.

Where whole-cell stem cell therapies depend on transplanting live cells, exosome-based approaches isolate just the signaling cargo. The therapeutic effect comes from what cells say, not from the cells themselves.

• 01Immunomodulatory

  MSC-Exos modulate both innate (macrophage polarization, NK function) and adaptive (T-cell, B-cell) immune responses. They temper exaggerated inflammatory signaling without globally suppressing the immune system.

• 02Anti-inflammatory

  Reductions in CRP, IL-6, ferritin, and D-dimer have been documented in MSC-Exo studies across acute respiratory inflammation, autoimmune flares, and post-viral inflammation patterns.

• 03Regenerative

  Carry growth factors and microRNAs that support tissue repair, mitochondrial recovery, and parenchymal regeneration in models of pulmonary injury, hepatic damage, and neural inflammation.

• 04Bioavailability

  Cross biological membranes that whole cells cannot, including the blood-brain barrier via intranasal administration — the delivery route used in the Xie et al. (2023) Alzheimer's trial.

Active peer-reviewed research covers post-acute COVID and ARDS, autoimmune disease (multiple sclerosis, systemic lupus, rheumatoid arthritis, inflammatory bowel disease, Sjögren's syndrome, autoimmune hepatitis), early Alzheimer's disease and MCI, and adjacent neuroimmune conditions.

Browse the curated literature catalogue with the full citations and plain-language summaries.

Investigational biologic products in the United States are regulated under Section 351 of the Public Health Service Act. The 351(a) pathway requires FDA pre-market review and approval and is distinct from the more permissive 361 pathway used for minimally manipulated, homologous-use tissue products.

RegenBio Care's structured clinical research programs operate within the 351(a) framework. Investigational products are delivered under appropriate IND/IDE coverage, with informed consent reviewed and approved by an Institutional Review Board (IRB) before any patient enrolls.

A small slice of the peer-reviewed literature behind the modality. Headline citations spanning COVID, Alzheimer's, and autoimmune applications.

• Sengupta et al.·Stem Cells and Development·2020

  Exosomes derived from bone marrow mesenchymal stem cells as treatment for severe COVID-19

  24 patients with severe COVID-19 ARDS received a single IV dose of bone marrow MSC-derived exosomes (ExoFlo). 83% survival rate, significant reduction in inflammatory markers (CRP, ferritin, D-dimer), and improvement in oxygenation within 72 hours.

  Read on PubMed
• Shen et al.·Frontiers in Immunology·2021

  Effects of Mesenchymal Stem Cell-Derived Exosomes on Autoimmune Diseases

  Substantial therapeutic progress documented across multiple sclerosis (MS), systemic lupus erythematosus (SLE), type-1 diabetes (T1DM), uveitis, rheumatoid arthritis (RA), and inflammatory bowel disease (IBD). MSC-exosomes show clear inhibitory effects on innate and adaptive immune effector cells.

  Read on PubMed
• Xie et al.·BMJ Open·2023

  Clinical safety and efficacy of allogenic human adipose mesenchymal stromal cells-derived exosomes in patients with mild to moderate Alzheimer's disease: a phase I/II clinical trial

  First-in-human MSC-Exo AD trial. Patients received intranasal allogenic adipose MSC-exosomes twice weekly for 12 weeks. In the medium-dose arm, ADAS-cog scores decreased by 2.33 points (cognitive improvement) and MoCA scores increased by 2.38 points at week 12 vs baseline. No adverse events reported.

  Read on PubMed